Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer
Corcept Therapeutics (NASDAQ: CORT) announced positive results from its pivotal Phase 3 ROSELLA trial of relacorilant combined with nab-paclitaxel in patients with platinum-resistant ovarian cancer. The trial met its primary endpoint, demonstrating a 30% reduction in disease progression risk compared to nab-paclitaxel alone.
Key findings include:
- Median progression-free survival of 6.5 months vs 5.5 months for control group
- Median overall survival of 16.0 months vs 11.5 months for control group
- No new safety concerns identified
The trial enrolled 381 patients across multiple countries without requiring biomarker selection. Based on these results, Corcept plans to submit a New Drug Application (NDA) in Q3 and a Marketing Authorization Application (MAA) in Europe shortly after.
Corcept Therapeutics (NASDAQ: CORT) ha annunciato risultati positivi dal suo studio pivotale di Fase 3 ROSELLA, che ha valutato il relacorilant in combinazione con nab-paclitaxel in pazienti con carcinoma ovarico resistente al platino. Lo studio ha raggiunto il suo obiettivo primario, mostrando una riduzione del 30% del rischio di progressione della malattia rispetto al nab-paclitaxel da solo.
I risultati chiave includono:
- Una sopravvivenza libera da progressione mediana di 6,5 mesi contro 5,5 mesi per il gruppo di controllo
- Una sopravvivenza globale mediana di 16,0 mesi contro 11,5 mesi per il gruppo di controllo
- Nessuna nuova preoccupazione per la sicurezza identificata
Lo studio ha arruolato 381 pazienti in diversi paesi senza richiedere la selezione di biomarcatori. Sulla base di questi risultati, Corcept prevede di presentare una Nuova Domanda di Farmaco (NDA) nel terzo trimestre e una Domanda di Autorizzazione alla Commercializzazione (MAA) in Europa poco dopo.
Corcept Therapeutics (NASDAQ: CORT) anunció resultados positivos de su ensayo pivotal de Fase 3 ROSELLA, que evaluó el relacorilant combinado con nab-paclitaxel en pacientes con cáncer de ovario resistente al platino. El ensayo cumplió su objetivo principal, demostrando una reducción del 30% en el riesgo de progresión de la enfermedad en comparación con nab-paclitaxel solo.
Los hallazgos clave incluyen:
- Una supervivencia libre de progresión mediana de 6.5 meses frente a 5.5 meses para el grupo de control
- Una supervivencia global mediana de 16.0 meses frente a 11.5 meses para el grupo de control
- No se identificaron nuevas preocupaciones de seguridad
El ensayo incluyó a 381 pacientes de varios países sin requerir selección de biomarcadores. Con base en estos resultados, Corcept planea presentar una Solicitud de Nuevo Medicamento (NDA) en el tercer trimestre y una Solicitud de Autorización de Comercialización (MAA) en Europa poco después.
Corcept Therapeutics (NASDAQ: CORT)는 백금 내성 난소암 환자에서 relacorilant과 nab-paclitaxel의 조합에 대한 주요 3상 ROSELLA 시험의 긍정적인 결과를 발표했습니다. 이 시험은 주요 목표를 달성하며, nab-paclitaxel 단독에 비해 질병 진행 위험을 30% 감소시켰습니다.
주요 발견 사항은 다음과 같습니다:
- 대조군에 비해 6.5개월의 중앙 무진행 생존 기간, 대조군은 5.5개월
- 대조군에 비해 16.0개월의 중앙 전체 생존 기간, 대조군은 11.5개월
- 새로운 안전성 문제는 발견되지 않음
이 시험은 바이오마커 선택 없이 여러 국가에서 381명의 환자를 등록했습니다. 이러한 결과를 바탕으로 Corcept는 3분기에 신약 신청서(NDA)를 제출하고, 그 후 유럽에서 마케팅 승인 신청서(MAA)를 제출할 계획입니다.
Corcept Therapeutics (NASDAQ: CORT) a annoncé des résultats positifs de son essai pivot de Phase 3 ROSELLA, combinant le relacorilant avec le nab-paclitaxel chez des patients atteints de cancer de l'ovaire résistant au platine. L'essai a atteint son objectif principal, démontrant une réduction de 30% du risque de progression de la maladie par rapport au nab-paclitaxel seul.
Les principales conclusions incluent:
- Une survie sans progression médiane de 6,5 mois contre 5,5 mois pour le groupe témoin
- Une survie globale médiane de 16,0 mois contre 11,5 mois pour le groupe témoin
- Aucune nouvelle préoccupation en matière de sécurité identifiée
L'essai a recruté 381 patients dans plusieurs pays sans nécessiter de sélection de biomarqueurs. Sur la base de ces résultats, Corcept prévoit de soumettre une Demande de Nouveau Médicament (NDA) au troisième trimestre et une Demande d'Autorisation de Mise sur le Marché (MAA) en Europe peu après.
Corcept Therapeutics (NASDAQ: CORT) gab positive Ergebnisse seiner entscheidenden Phase-3-Studie ROSELLA bekannt, in der Relacorilant in Kombination mit Nab-Paclitaxel bei Patienten mit platinresistentem Ovarialkarzinom untersucht wurde. Die Studie erreichte ihr primäres Ziel und zeigte eine 30%ige Reduktion des Risikos für Krankheitsprogression im Vergleich zu Nab-Paclitaxel allein.
Wichtige Ergebnisse sind:
- Medianes progressionsfreies Überleben von 6,5 Monaten gegenüber 5,5 Monaten für die Kontrollgruppe
- Medianes Gesamtüberleben von 16,0 Monaten gegenüber 11,5 Monaten für die Kontrollgruppe
- Keine neuen Sicherheitsbedenken identifiziert
Die Studie umfasste 381 Patienten aus mehreren Ländern, ohne dass eine Biomarker-Auswahl erforderlich war. Basierend auf diesen Ergebnissen plant Corcept, im dritten Quartal einen Antrag auf Zulassung eines neuen Medikaments (NDA) einzureichen und kurz danach einen Antrag auf Marktzulassung (MAA) in Europa.
- Met primary endpoint with 30% reduction in disease progression risk
- Significant 4.5-month improvement in overall survival (16.0 vs 11.5 months)
- Clean safety profile with no new safety signals
- Potential to become new standard of care in platinum-resistant ovarian cancer
- NDA submission planned for Q3 with European MAA to follow
- Modest 1-month improvement in progression-free survival (6.5 vs 5.5 months)
Insights
Corcept's Phase 3 ROSELLA trial results represent a significant clinical and potential commercial breakthrough. The trial met its primary endpoint with relacorilant plus nab-paclitaxel showing a
These robust efficacy metrics were achieved without increasing the side effect burden - a critical factor for cancer treatments where quality of life considerations are paramount. The company's planned NDA submission in Q3 puts Corcept on a clear regulatory pathway, with European applications to follow.
For platinum-resistant ovarian cancer - a notoriously difficult-to-treat indication with effective options - these results could establish relacorilant plus nab-paclitaxel as a new standard of care. The trial's design with dual primary endpoints (either being sufficient for success) and the enrollment across multiple global regions strengthens the regulatory case.
The collaboration with prestigious oncology research networks (GOG-F, ENGOT, APGOT, LACOG, and ANZGOG) adds credibility to these findings and should facilitate eventual market adoption if approved. This represents a potential significant expansion of Corcept's commercial portfolio beyond its current cortisol modulation products.
The ROSELLA trial results mark a meaningful advancement for platinum-resistant ovarian cancer patients. The
What's particularly noteworthy is achieving these survival benefits without increasing toxicity burden. In platinum-resistant settings, where patients have already undergone multiple treatment lines, the therapeutic index (benefit vs. side effects) becomes increasingly important.
Mechanistically, relacorilant blocks cortisol activity at glucocorticoid receptors, potentially reducing treatment resistance and enhancing chemotherapy effectiveness. This approach addresses a fundamental challenge in recurrent disease - the development of resistance mechanisms.
The trial's design without biomarker selection suggests broad applicability across the patient population rather than targeting a specific genetic subtype. This could expand the eligible patient population substantially compared to biomarker-restricted therapies.
Given the effective options in platinum-resistant setting and the consistent benefit shown from Phase 2 (published in JCO) through this Phase 3 validation, relacorilant plus nab-paclitaxel could indeed represent a significant treatment advance that changes clinical practice.
- Relacorilant plus nab-paclitaxel improved progression-free and overall survival and did not increase side effect burden
-
Results will support a New Drug Application (NDA) in
the United States and a Marketing Authorization Application (MAA) inEurope - Relacorilant plus nab-paclitaxel has the potential to become a new standard of care for patients with platinum-resistant ovarian cancer
In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in risk of disease progression compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.70; p-value: 0.008). Their median PFS-BICR was 6.5 months, compared to 5.5 months in patients who received nab-paclitaxel alone. At an interim evaluation of overall survival (OS), patients treated with relacorilant plus nab-paclitaxel had a significant improvement in OS, with a median OS of 16.0 months, compared to 11.5 months for patients receiving nab-paclitaxel alone (hazard ratio: 0.69; p-value: 0.012). Relacorilant was well-tolerated and no new safety signals were observed. As was the case in the company’s Phase 2 trial, safety and tolerability were comparable in the two groups.
Complete results from ROSELLA will be presented at a medical conference this year. Results from Corcept’s Phase 2 trial of relacorilant in patients with platinum-resistant ovarian cancer were published in the Journal of Clinical Oncology in June 2023.
The ROSELLA trial enrolled 381 patients with platinum-resistant ovarian cancer at sites in
“Patients with advanced ovarian cancer have few good treatment options and, unfortunately, patients with recurrent disease eventually develop resistance to available therapies. The ROSELLA results represent an important advancement in the development of a treatment for patients with platinum-resistant ovarian cancer,” said Alexander B. Olawaiye, M.D., Director of gynecological cancer research at Magee-Women’s Hospital of the University of
“Platinum-resistant ovarian cancer poses a significant treatment challenge. The ROSELLA results demonstrate that relacorilant in combination with nab-paclitaxel has the potential to become a key strategy to help improve patient outcomes,” said Domenica Lorusso, M.D., Ph.D., Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X,
“The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We deeply appreciate the patients and investigators who participated in the trial, and we look forward to presenting the trial’s full results in the coming months. We expect to submit our NDA in the third quarter and our MAA shortly thereafter.”
The ROSELLA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).
About Relacorilant
Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to ovarian cancer, including endogenous hypercortisolism (Cushing’s syndrome) and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer.
About Platinum-Resistant Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have “platinum-resistant” disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in
About Corcept’s Oncology Programs
Cortisol helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response, which weakens its ability to fight disease.
About Corcept Therapeutics
For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators and GR antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC’s website.
In this press release, forward-looking statements include statements concerning: the results of our ROSELLA trial; relacorilant’s efficacy, safety and other clinical attributes and its potential to receive regulatory approval and become a standard-of-care treatment for patients with platinum-resistant ovarian cancer; regulatory oversight of relacorilant and the scope, pace and outcome of potential NDA and MAA submissions; relacorilant’s acceptance and use by physicians and patients and its commercial prospects; and the scope and protective power of relacorilant’s orphan drug designation and our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
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Source: Corcept Therapeutics Incorporated
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